Fingolimod Lupin 0,5 mg harde capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FINGOLIMODHYDROCHLORIDE SAMENSTELLING overeenkomend met ; FINGOLIMOD

Beschikbaar vanaf:

Lupin Europe GmbH Hanauer Landstrasse 139-143 60314 FRANKFURT AM MAIN (DUITSLAND)

INN (Algemene Internationale Benaming):

FINGOLIMODHYDROCHLORIDE COMPOSITION corresponding to ; FINGOLIMOD

farmaceutische vorm:

Capsule, hard

Samenstelling:

ALUMINIUMMAGNESIUMMETASILICAAT, type 1A,B of C ; AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; NATRIUMSTEARYLFUMARAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-03-30

Bijsluiter

33
PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fingolimod Lupin 0,5 mg harde capsules
fingolimod
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT
[Product name] IS AND WHAT IT IS USED FOR
WHAT [PRODUCT NAME] IS
Fingolimod contains the active substance fingolimod.
WHAT
[
[
N
N
A
A
T
T
I
I
O
O
N
N
A
A
L
L
N
N
A
A
M
M
E
E
]
] IS USED FOR
[
[
P
P
r
r
o
o
d
d
u
u
c
c
t
t
n
n
a
a
m
m
e
e
]
]
is used in adults and in children and adolescents (10 years of age and
above) to treat
relapsing remitting multiple sclerosis (MS), more specifically in:
- Patients who have failed to respond despite treatment with an MS
treatment.
or
- Patients who have rapidly evolving severe MS.
[
[
P
P
r
r
o
o
d
d
u
u
c
c
t
t
n
n
a
a
m
m
e
e
]
] does not cure MS, but it helps to reduce the number of relapses and
to slow down the
progression of physical disabilities due to MS.
WHAT IS MULTIPLE SCLEROSIS
MS is a long-term condition that affects the central nervous system
(CNS), comprised of the brain and
spinal cord. In MS inflammation destroys the protect

Productkenmerken

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
2
SUMMARY OF PRODUCT CHARACTERISTICS
3
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
[Product name] 0.5mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fingolimod hydrochloride corresponding to 0.5mg
fingolimod.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Hard gelatin capsule of 15.8 ± 0.4mm (size 3)
with bright yellow opaque cap and white opaque body,
imprinted with "FG 0.5" on cap in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product name] is indicated as single disease modifying therapy in
highly active relapsing remitting
multiple sclerosis for the following groups of adult patients and
paediatric patients aged 10 years and
older:
- Patients with highly active disease despite a full and adequate
course of treatment with at least one
disease modifying therapy (for exceptions and information about
washout periods see sections 4.4 and
5.1).
or
- Patients with rapidly evolving severe relapsing remitting multiple
sclerosis defined by 2 or more
disabling relapses in one year, and with 1 or more Gadolinium
enhancing lesions on brain MRI or a
significant increase in T2 lesion load as compared to a previous
recent MRI.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by a physician
experienced in multiple sclerosis.
Posology
In adults, the recommended dose of [Product name] is one 0.5 mg
capsule taken orally once daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body
weight:
- Paediatric patients with body weight ≤40 kg: one 0.25 mg capsule
taken orally once daily.
- Paediatric patients with body weight >40 kg: one 0.5 mg cap